UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022460
Receipt number R000025883
Scientific Title Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis
Date of disclosure of the study information 2016/05/26
Last modified on 2019/03/29 01:24:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis

Acronym

Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis

Scientific Title

Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis

Scientific Title:Acronym

Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis

Region

Japan


Condition

Condition

Lumbar degenerative spondylolisthesis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Surgical treatment for the lumbar degenerative spondylolisthesis (DS) is commonly performed.
In general, decompression with fusion for the patient with severe slippage or instability has reached consensus. Operative procedure for the patient without severe slippage is still in discussion; decompression alone or that with fusion. Some previous studies showed no significant difference between them in clinical results or complication rates. On the other hand, some studies showed decompression with fusion have advantages in clinical results, and some showed differences in complication rates. The purpose of this study is to clarify the existence of superiority in two procedures for the DS patients without severe slippage.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluate the efficacy of treatment using clinical scores below preoperatively, postoperative 3months, 6months, 1year, and 2years; Rolland-Morris Disability Questionnaire(RDQ), Oswestry Disability Index (ODI) 2.0, Visual Analogue Scale (VAS)of low back pain and leg pain

Key secondary outcomes

Reoperation rate, complication rate of surgery (infection, hematoma, dural tear, restenosis, progression of slippage, adjacent segmental disease, nonunion), medical complication (heart failure, pneumonia, renal failure, etc)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Posterior lumbar decompression

Interventions/Control_2

Posterior lumbar interbody fusion/ Transforaminal lumbar interbody fusion

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with single level spondylolisthesis (slippage at least 3mm in flexion position, and %slip less than 25%), who have leg neurological symptoms (pain, numbness, and so on) resistant to conservative therapy

Key exclusion criteria

Patients who cannot get MRI, patients with previous lumbar surgery, patients with foraminal stenosis at the slippage level and neurological symptoms of same level, patients with degenerative lumbar scoliosis (Cobb angle >20 degrees), patients whose QOL assessment is significantly difficult because of comorbid illness such as Parkinson's disease, Renal failure requiring dialysis, dementia, etc

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takamasa
Middle name
Last name Watanabe

Organization

Hakodate central general hospital

Division name

Department of orthopedic surgery

Zip code

0408585

Address

33-2 honcho, Hakodate city, Hokkaido

TEL

0138-52-1231

Email

penyomasa@gmail.com


Public contact

Name of contact person

1st name Takamasa
Middle name
Last name Watanabe

Organization

Hakodate central general hospital

Division name

Department of orthopedic surgery

Zip code

0408585

Address

33-2 honcho, Hakodate city, Hokkaido

TEL

0138-52-1231

Homepage URL


Email

penyomasa@gmail.com


Sponsor or person

Institute

Hakodate central general hospital, Department of orthopedic surgery

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of Hakodate Central General Hospital

Address

33-2 honcho, Hakodate city, Hokkaido

Tel

0138-52-1231

Email

saito-h@hakochu-hp.gr.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

函館中央病院(北海道)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 26 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2016 Year 05 Month 07 Day

Date of IRB

2016 Year 05 Month 26 Day

Anticipated trial start date

2016 Year 05 Month 26 Day

Last follow-up date

2020 Year 09 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 25 Day

Last modified on

2019 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025883


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name